Who is sponsoring NCT02942160?

NCT02942160 is sponsored by Endo Pharmaceuticals.

What drugs are being tested in NCT02942160?

Interventions in NCT02942160: Collagenase Clostridium Histolyticum.

What condition does NCT02942160 study?

NCT02942160 studies Edematous Fibrosclerotic Panniculopathy, Cellulite.

Is NCT02942160 still recruiting?

NCT02942160 is currently completed. Last updated 24 November 2020.

Are results published for NCT02942160?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-24 · How we verify

NCT02942160

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Completed Phase 2 Results posted Last updated 24 November 2020

What this trial tests

Phase 2 trial testing Collagenase Clostridium Histolyticum in Edematous Fibrosclerotic Panniculopathy in 259 participants. Completed in 14 June 2018.

Timeline

5 October 2016

Primary endpoint
14 June 2018

14 June 2018

Quick facts

Lead sponsor	Endo Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	259
Start date	5 October 2016
Primary completion	14 June 2018
Estimated completion	14 June 2018
Sites	15 locations across United States

Drugs / interventions tested

Collagenase Clostridium Histolyticum — full drug profile →

Conditions studied

Edematous Fibrosclerotic Panniculopathy — all drugs for Edematous Fibrosclerotic Panniculopathy →
Cellulite — all drugs for Cellulite →

Sponsor

Endo Pharmaceuticals — full company profile →

Who can join

18 and older, female only, with Edematous Fibrosclerotic Panniculopathy or Cellulite. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase Primary · Day 180 to Day 360

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatm

Observation Visit Day 180

Group	Value	95% CI
EN3835 Treatment Regions	19
EN3835 Treatment Regions	0

Observation Visit Day 360

Group	Value	95% CI
EN3835 Treatment Regions	16
EN3835 Treatment Regions	0

Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase Secondary · Day 180 to Day 360

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatmen

Observation Durability Visit Day 180

Group	Value	95% CI
EN3835 Treatment Regions	50
EN3835 Treatment Regions	3

Observation Durability Visit Day 360

Group	Value	95% CI
EN3835 Treatment Regions	43
EN3835 Treatment Regions	2

Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase Secondary · Day 540 to Day 720

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from b

Long-term Durability Visit Day 540

Group	Value	95% CI
EN3835 Treatment Regions	7
EN3835 Treatment Regions	0

Long-term Durability Visit Day 720

Group	Value	95% CI
EN3835 Treatment Regions	7
EN3835 Treatment Regions	0

Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase Secondary · Day 540 to Day 720

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from bas

Long-term Durability Visit Day 540

Group	Value	95% CI
EN3835 Treatment Regions	22
EN3835 Treatment Regions	1

Long-term Durability Visit Day 720

Group	Value	95% CI
EN3835 Treatment Regions	21
EN3835 Treatment Regions	2

CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase Secondary · Baseline (in EN3835-201 Study) to Observation Day 360

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.

Change from Baseline on Day 71 (EN3835-201 Study)

Group	Value	95% CI
EN3835 0.84 mg	-0.8	± 0.88
Placebo	-0.3	± 0.60

Change from Baseline-Observation Visit Day 180

Group	Value	95% CI
EN3835 0.84 mg	-0.6	± 0.80
Placebo	-0.2	± 0.67

Change from Baseline-Observation Visit Day 270

Group	Value	95% CI
EN3835 0.84 mg	-0.6	± 0.76
Placebo	-0.1	± 0.63

Change from Baseline-Observation Visit Day 360

Group	Value	95% CI
EN3835 0.84 mg	-0.9	± 0.86
Placebo	-0.5	± 0.83

CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment Secondary · Day 22 to Day 360

Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Stu

Change from Baseline (BL) to Treatment Day 22

Group	Value	95% CI
EN3835 Treatment Regions	-0.6	± 0.68

Change from Baseline (BL) to Treatment Day 43

Group	Value	95% CI
EN3835 Treatment Regions	-0.8	± 0.71

Change from Baseline (BL) to Treatment Day 71

Group	Value	95% CI
EN3835 Treatment Regions	-1.0	± 0.79

Change from BL to Treatment Observation Day 180

Group	Value	95% CI
EN3835 Treatment Regions	-1.0	± 0.80

Change from BL to Treatment Observation Day 360

Group	Value	95% CI
EN3835 Treatment Regions	-0.9	± 0.77

PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment Secondary · Day 22 to Day 360

Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN

Change from Baseline (BL) to Treatment Day 22

Group	Value	95% CI
EN3835 Treatment Regions	-0.5	± 0.64

Change from Baseline (BL) to Treatment Day 43

Group	Value	95% CI
EN3835 Treatment Regions	-0.8	± 0.75

Change from Baseline (BL) to Treatment Day 71

Group	Value	95% CI
EN3835 Treatment Regions	-1.1	± 0.82

Change from BL to Treatment Observation Day 180

Group	Value	95% CI
EN3835 Treatment Regions	-1.0	± 0.83

Change from BL to Treatment Observation Day 360

Group	Value	95% CI
EN3835 Treatment Regions	-1.0	± 0.83

Change From Baseline on the Hexsel CSS Total Score During the Observation Phase Secondary · Baseline (in EN3835-201 Study) to Day 360

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from "0" (no cellulite) to "15" (ext

Baseline Point (in EN3835-201 Study)

Group	Value	95% CI
EN3835 0.84 mg	10.7	± 1.32
Placebo	10.4	± 1.41

Day 71 Reference Point (in EN3835 Study)

Group	Value	95% CI
EN3835 0.84 mg	9.0	± 2.42
Placebo	9.7	± 2.20

Change from Baseline (Day 71)

Group	Value	95% CI
EN3835 0.84 mg	-1.8	± 2.22
Placebo	-0.8	± 1.81

Observation Visit Day 360

Group	Value	95% CI
EN3835 0.84 mg	8.6	± 2.40
Placebo	9.5	± 1.35

Change from Baseline (Day 360)

Group	Value	95% CI
EN3835 0.84 mg	-2.2	± 2.34
Placebo	-1.2	± 1.47

Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits Secondary · Day 540 to Day 720

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3", with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely

Baseline (in EN3835-201 Study)

Group	Value	95% CI
EN3835 Treatment Regions	10.6	± 1.43

Long-term Durability Visit Day 540-Change from BL

Group	Value	95% CI
EN3835 Treatment Regions	-3.5	± 1.76

Long-term Durability Visit Day 720-Change from BL

Group	Value	95% CI
EN3835 Treatment Regions	-2.9	± 1.74

Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment Secondary · Baseline - Day 360

The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of "0" to a high of "3". The total score is a summation of all 5 features and can range from "0" (no cellulite) to "15" (extremely severe cellulite) and is designated in this study as

Second EN3835 Treatment: Baseline

Group	Value	95% CI
EN3835 Treatment Regions	10.5	± 1.44

Second EN3835 Treatment: Day 71

Group	Value	95% CI
EN3835 Treatment Regions	8.3	± 2.41

Second EN3835 Treatment: Change from Baseline

Group	Value	95% CI
EN3835 Treatment Regions	-2.2	± 2.32

Second EN3835: Treatment Observation Day 360

Group	Value	95% CI
EN3835 Treatment Regions	8.1	± 2.51

Second EN3835: Change from Baseline

Group	Value	95% CI
EN3835 Treatment Regions	-2.4	± 2.37

Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase Secondary · Day 360

Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment

Very Much Improved (3)

Group	Value	95% CI
EN3835 0.84 mg	4
Placebo	0

Much Improved (2)

Group	Value	95% CI
EN3835 0.84 mg	23
Placebo	0

Improved (1)

Group	Value	95% CI
EN3835 0.84 mg	36
Placebo	4

No Change (0)

Group	Value	95% CI
EN3835 0.84 mg	32
Placebo	14

Worse (-1)

Group	Value	95% CI
EN3835 0.84 mg	2
Placebo	1

Much Worse (-2)

Group	Value	95% CI
EN3835 0.84 mg	0
Placebo	0

Very Much Worse (-3)

Group	Value	95% CI
EN3835 0.84 mg	0
Placebo	0

Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment Secondary · Day 71 - Day 360

Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from "+3" (Very much improved) to "-3" (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that r

Second EN3835 Treatment: Treatment Day 71

Group	Value	95% CI
EN3835 Treatment Regions	10
EN3835 Treatment Regions	38
EN3835 Treatment Regions	73
EN3835 Treatment Regions	35

Second EN3835 Tx: Treatment Observation Day 360

Group	Value	95% CI
EN3835 Treatment Regions	5
EN3835 Treatment Regions	33
EN3835 Treatment Regions	64
EN3835 Treatment Regions	31

Adverse events — posted to ClinicalTrials.gov

Time frame: All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Observation Phase

Serious: 1/259 (0%)

Deaths: 0/259

EN3835 Treatment Phase

Serious: 4/200 (2%)

Deaths: 1/200

Serious adverse events (5 terms)

Reaction	System	Observation Phase	EN3835 Treatment Phase
Appendicitis	Infections and infestations	—	—
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Spontaneous Miscarriage	Pregnancy, puerperium and perinatal conditions	—	—
Hypertensive Urgency	Vascular disorders	—	—
Death from Motor Vehicle Accident	Injury, poisoning and procedural complications	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Observation Phase	EN3835 Treatment Phase
Injection site bruising	General disorders	—	—
Injection site pain	General disorders	—	—
Injection site nodule	General disorders	—	—
Injection site pruritus	General disorders	—	—
Injection site swelling	General disorders	—	—
Injection site discolouration	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—

Most-reported serious reactions: Appendicitis, Breast Cancer, Spontaneous Miscarriage, Hypertensive Urgency, Death from Motor Vehicle Accident.

Data from ClinicalTrials.gov NCT02942160 adverse events section.

Sponsor's own description

A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials.
Kaufman-Janette J, Joseph JH, Kaminer MS, Clark J, et al · · 2021 · cited 26× · PMID 33840781 · DOI 10.1097/dss.0000000000002952
Efficacy, Safety, and Durability of Response of Collagenase Clostridium Histolyticum-aaes for Treating Cellulite.
Kaufman-Janette JA, Bass LS, Xiang Q, McLane MP, et al · · 2020 · cited 11× · PMID 33425621 · DOI 10.1097/gox.0000000000003316
Selected Poster Abstracts from MauiDerm 2019 for Dermatologists
· 2019

Verify or expand the search:

Other trials of Collagenase Clostridium Histolyticum

Trials testing the same drug.

NCT03329989 — Safety and Effectiveness of EN3835 in the Treatment of EFP in Women · Phase 2 · completed

Other Endo Pharmaceuticals trials

Trials by the same sponsor.

NCT06169319 — A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA) · Phase 2 · completed
NCT05873595 — Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease · terminated
NCT05877066 — Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture · terminated
NCT05419505 — Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks · Phase 2 · completed
NCT05254457 — Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02942160 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endo Pharmaceuticals
Last refreshed: 24 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02942160.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing